The Biostatistical Core will provide biostatistical support services for the investigators in this PPG including those in other cores. This work will involve helping with the experimental designs of the studies, providing advice and services on randomization and blinding, calculation of sample sizes for projected studies, and to be a repository for all of the data in these inter-related studies. In addition, the Core will provide aid in quality control for the investigators, and do the biostatistical analysis of the data generated in the clinical trial and the laboratory experiments, and will collaborate in writing reports and journal articles.